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510(k) Data Aggregation
(241 days)
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
The Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The sheath curve can be visualized when used with compatible Carto 3 EP Navigation Systems.
The Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, and fluid infusion. A handle equipped with a rotating collar to deflect the tip clockwise ≤ 180° and counterclockwise ≤ 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to allow fluoroscopic visualization.
This document describes the FDA's 510(k) clearance for the Reprocessed Carto Vizigo 8.5F Bi-Directional Guiding Sheath (K212165). This is a reprocessed medical device, and the submission focuses on demonstrating that the reprocessed device is substantially equivalent to the original predicate device.
The provided text does not contain information related to a study involving AI, machine learning, or complex algorithms. The device is a physical medical instrument (a guiding sheath used in cardiac procedures). Therefore, many of the requested criteria, such as "Sample size used for the test set and the data provenance," "Number of experts used to establish the ground truth for the test set," "Adjudication method," "Multi-reader multi-case (MRMC) comparative effectiveness study," "Stand-alone (algorithm only) performance," "Type of ground truth," "Sample size for the training set," and "How ground truth for the training set was established" are not applicable to this type of device and submission.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a reprocessed device like this primarily revolve around demonstrating that the reprocessed device is as safe and effective as the original, single-use device. This is typically shown through functional, material, and safety testing (e.g., sterilization, biocompatibility, mechanical integrity).
Here's an interpretation of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a specific table with numerical acceptance criteria and direct performance metrics in the way one might expect for an AI algorithm (e.g., sensitivity, specificity). Instead, substantial equivalence for a reprocessed device is shown by demonstrating that the reprocessed device meets the same performance characteristics as the predicate device.
| Acceptance Criterion (Type of Test) | Reported Device Performance (Conclusion) |
|---|---|
| Biocompatibility | Tested to ensure safety for patient contact. |
| Cleaning Validation | Tested to ensure effective removal of contaminants. |
| Sterilization Validation | Tested to ensure the device is sterile after reprocessing. |
| Functional testing: | |
| * Visual Inspection | Passed (Inspected prior to packaging and labeling). |
| * Dimensional Verification | Passed (No changes in claims, clinical applications, patient populations, performance specifications). |
| * Dynamic Continuity | Passed (No changes in claims, clinical applications, patient populations, performance specifications). |
| * Simulated Use | Passed (Purpose, design, materials, function, and intended use are identical to the predicate). |
| * Leak | Passed (No changes in claims, clinical applications, patient populations, performance specifications). |
| Mechanical Characteristics | Passed (No changes in claims, clinical applications, patient populations, performance specifications). |
| Electrical Safety Testing: | |
| * Dielectric and Current Leakage | Tested to ensure electrical safety. |
| Packaging Validation | Tested to ensure package integrity and sterility maintenance. |
Overall Conclusion: Innovative Health concludes that the Reprocessed Carto Vizigo Bi-Directional Guiding Sheath is substantially equivalent to the predicate devices described herein, implying all functional and safety tests were met.
2. Sample size used for the test set and the data provenance
Not Applicable for this type of device. The testing performed is physical/bench testing on representative reprocessed devices, not a test set of data like in AI/ML studies. The "provenance" would be the manufactured/reprocessed devices themselves, subject to the testing protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. Ground truth in this context is established through validated physical, chemical, and electrical testing methods and standards, performed by qualified laboratory personnel, not by medical experts making diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. This is a physical device re-processing submission, not an AI/ML diagnostic system requiring expert adjudication of results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, "ground truth" is fundamentally defined by meeting established engineering specifications, safety standards (e.g., ISO, ASTM), and clinical performance criteria for physical devices. This is verified through:
- Biocompatibility testing: Conformance to standards like ISO 10993.
- Cleaning validation: Demonstrated removal of biological soil to predefined levels.
- Sterilization validation: Demonstrated sterility assurance level (SAL).
- Functional and Mechanical testing: Meeting pre-defined specifications for dimensions, leak integrity, steerability, electrical safety, etc., often benchmarked against the original predicate device's performance.
8. The sample size for the training set
Not Applicable. This is not an AI/ML device that requires a training set. The "training" in manufacturing comes from established and validated reprocessing procedures.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant. For a reprocessed device, established procedures and performance specifications for the predicate device guide the reprocessing "training" and validation.
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